Italian Medicines Agency grants marketing authorization to ILUVIEN for chronic DME treatment

Jun 23 2014

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The ILUVIEN marketing authorization notice was published on June 18 in the Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government. Designated a C Class product in Italy, ILUVIEN will be available initially to private paying patients, and pSivida's licensee, Alimera Sciences, is pursuing H Class designation for ILUVIEN with the Italian regulatory authorities, which, if granted, would expand patient access to the product.

The Italian authorization marks the seventh national approval in the EU. ILUVIEN is authorized in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the U.K. and Germany. Alimera is also engaged in a Repeat Use Procedure through Mutual Recognition (MRP) to obtain a positive opinion for approval from another 10 EU countries. In the United States, ILUVIEN is awaiting a decision from the FDA on the refiled NDA, with a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014.

"We are very pleased that ILUVIEN has been granted marketing authorization in all seven EU countries where initial applications have been submitted," said Dr. Paul Ashton, President and CEO of pSivida. "Additionally, should ILUVIEN be approved by the FDA, we are entitled to a $25 million milestone payment from Alimera in addition to net profit payments on Alimera's sales of ILUVIEN."

SOURCE pSivida Corp.